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Evaluation of an external lubrication system implemented in a compaction simulator
Cedrine de Backere1, Thomas De Beer2, Chris Vervaet1
1Laboratory of Pharmaceutical Technology, Department of Pharmaceutics, Ghent University, Ottergemsesteenweg 460, B-9000 Ghent, Belgium.
International Journal of Pharmaceutics
|July 30, 2020
Summary
External lubrication of pharmaceutical formulations minimizes negative effects like reduced tensile strength. This method, using a compaction simulator, showed promising results for lubricant-sensitive products.
Area of Science:
- Pharmaceutical Technology
- Materials Science
Background:
- Internal blending of magnesium stearate (Mg-stearate) can negatively impact tablet properties, including tensile strength and disintegration time.
- External lubrication offers a potential alternative to mitigate these adverse effects in pharmaceutical manufacturing.
Purpose of the Study:
- To investigate an external lubrication system using a compaction simulator.
- To evaluate the influence of spraying time and atomizing pressure on tablet properties.
- To compare external lubrication with traditional internal lubrication.
Main Methods:
- An external lubrication system was implemented in a compaction simulator.
- Four common fillers and two model drugs were used in the study.
- The effects of spraying time and atomizing pressure were analyzed.
Main Results:
- External lubrication significantly impacted ejection forces but not tensile strength or disintegration time.
- Compared to internal lubrication, external lubrication resulted in similar or lower ejection forces.
- Lower concentrations of magnesium stearate were effective with external lubrication, avoiding tensile strength reduction and prolonged disintegration.
Conclusions:
- External lubrication is a viable alternative to internal lubrication, especially for lubricant-sensitive formulations.
- Process parameters of external lubrication systems can be optimized to control tablet properties.
- The study highlights the potential of external lubrication to improve pharmaceutical tablet manufacturing.
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